OB/GYN PACKS— 510(k) K951081

Substantially Equivalent

Sterile Concepts, Inc.

FDA 510(k) clearance K951081 for OB/GYN PACKS, Substantially Equivalent on 1995-11-13. Applicant: Sterile Concepts, Inc.. Device class: 2.

Clearance details

Applicant: Sterile Concepts, Inc.
Product code: Code KNA
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1995-03-09
Decision date: 1995-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, VA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Sterile Concepts, Inc.

K951231 — ORTHOPEDIC PACKS1995-12-01
K952539 — RADIOLOGY PACKS1995-07-14
K951478 — GENERAL AND PLASTIC SURGERY PACKS1995-06-13
K944139 — DENTAL HYGIENE TRAY1994-12-15
K943047 — IV START KITS1994-09-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.